Oppenheim R C, Gillies I R
J Pharm Pharmacol. 1986 May;38(5):344-7. doi: 10.1111/j.2042-7158.1986.tb04584.x.
Plastic ampoules of Water for Injections, JP, and Injection Sodium Chloride, JP, were investigated to determine their particle load. Four batches were studied. The ampoules were twist-opened as they would be in the clinical setting and the total particle load, both inherent and that created in opening, was determined by reading the contents with a HIAC 420 particle counter with a CMB 60 sensor. The total particle content was found to be minimal, easily complying with world L.V.P. standards and the S.V.P. standard of the USP XXI. The number of particles found in these opened plastic ampoules was significantly lower than that found in clinically snap-opened glass ampoules and also slightly lower than that found in laboratory heat-opened glass ampoules. Whilst the plastic ampoule has a restricted application because it is not suitable for all drugs, it is concluded that when they are used as the immediate container for Water for Injections and Injection Sodium Chloride they are highly effective in reducing the particulate contamination generated in opening.
对日本药典中的注射用水塑料安瓿和氯化钠注射液塑料安瓿进行了研究，以确定其颗粒负载量。共研究了四个批次。这些安瓿按照临床使用时的方式扭开，通过使用配备CMB 60传感器的HIAC 420颗粒计数器读取内容物，来确定固有颗粒负载量以及打开安瓿时产生的颗粒负载量。结果发现，总颗粒含量极少，轻松符合世界低容量注射剂标准以及美国药典 XXI 的小容量注射剂标准。在这些打开的塑料安瓿中发现的颗粒数量明显低于临床折断打开的玻璃安瓿中发现的颗粒数量，也略低于实验室加热打开的玻璃安瓿中发现的颗粒数量。虽然塑料安瓿由于不适用于所有药物而应用受限，但得出的结论是，当它们用作注射用水和氯化钠注射液的直接容器时，在减少打开时产生的颗粒污染方面非常有效。
